BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860663 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00760
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM DEVICE WAS DROPPED. ANALYSIS FOUND THE BATTERY DRAWER IS BROKEN AND THE BATTERY CONTACTS ARE COMPRESSED. ANALYSIS ALSO FOUND THE UPPER AND LOWER CASES ARE BROKEN AND PAINTED. RING COVER, BOTH BAIL COVERS, RING AND BOTH BAILS ARE MISSING. LEAD FLEX COVER IS BROKEN, KEYBOARD IS SCRATCHED, AND SERIAL NUMBER LABEL IS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS DROPPED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND CALIBRATION, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339779 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1